Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We were unable to run the trial because of inadequate resources (staffing). The principal investigator also moved countries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.
Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS | Experimental | Participants will receive Active-TENS along with SMCE and UHEP. Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes. |
|
| SMCE | Experimental | Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks. |
|
| UHEP | Active Comparator | Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
|
| Measure | Description | Time Frame |
|---|---|---|
| Disability (Nepali version of Oswestry Disability Index (NODI) | Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (Numerical Pain Rating Scale (NPRS) | Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours. | 2 weeks |
| Pain intensity (Numerical Pain Rating Scale (NPRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain and disability (Global Rating of Change (GROC) | Global Rating of Change (GROC) - The fifteen-point global rating scale will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. The global rating will be administered at the follow-up examinations only. |
Inclusion Criteria:
Exclusion Criteria:
Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
Signs consistent with nerve root compression, this includes any one of the following:
Prior surgery to the lumbar spine or buttock
Current pregnancy
Past medical history of osteoporosis or spinal compression fracture
Participants who do not provide informed consent for the study
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saurab Sharma, MPT | Kathmandu University School of Medical Sciences, Nepal | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| SMCE | Other | Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities. |
|
|
| UHEP | Other | All the participants will receive the following treatments:
|
|
|
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours. |
| 6 months |
| Disability (Nepali version of Oswestry Disability Index (NODI) | Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875) | 6 months |
| 2 weeks |
| Changes in pain and disability (Global Rating of Change (GROC) | Using Global rating of change (GROC) | 6 months |
| Need for medication (using frequency and dosage and types of analgesics used) | using frequency and dosage and types of analgesics used | 6 months |
| Need for follow up (number of treatment sessions in past six months will be recorded) | number of treatment sessions in past six months will be recorded | 6 months |
| Adverse events | numbers of adverse events are noted down using a questionnaire | 6 months |
| Fear avoidance (Fear avoidance belief questionnaire (FABQ) | Fear avoidance belief questionnaire (FABQ) - The FABQ is a 16-item scale that assesses the influence of fear avoidance behaviors on physical and work activities. Each item is scored from 0-6 with possible scores ranging between 0-42 and higher scores representing increased fear-avoidance beliefs. | 6 months |
| Pain Catastrophizing (Pain catastrophizing Scale (PCS) | Pain catastrophizing Scale (PCS) - Nepali translation of PCS is a 13-item scale that assesses the pain catastrophizing. Pain catastrophizing is an exaggerated, negative focus on pain and is related to psychological distress, pain severity, and other negative outcomes in pain population. Participants responded to each item using a Likert-type scale from 0 ('not at all') to 4 ('all the time'). | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |